Ask Dr. Hull

Is Splenda Safe For Diabetics?

The issue of diabetic safety is unresolved based on the research submitted. In anticipation of the potential widespread use of sucralose (Splenda) in persons with diabetes, and to address concerns raised by the Diabetic Association in Canada, McNeil Nutritionals performed a series of “requested” clinical studies on diabetes. However, the tests were neither well executed nor well documented, but McNeil represents Splenda as safe for diabetics (according to their research). Nonetheless (according to their research), the accuracy of this statement is debatable.

In 1995, because of concern pertaining to the results observed in diabetic patients treated with sucralose in the previously submitted and evaluated clinical studies, McNeil, themselves, requested the FDA withhold its final decision on the safety of sucralose until that observation could be further investigated. At that time, McNeil initiated additional studies with the main objective of evaluating the effects sucralose would have on glucose homeostasis in patients with diabetes mellitus. These additional tests run by McNeil were not performed with the same test protocols/parameters in the studies previously submitted to the FDA. According to the FDA documents, some of the tests were not actually performed on humans, but merely on blood samples within test tubes. Yet the results submitted were documented to equate the previous uncertain human diabetic studies.

For example, the FDA concluded that sucralose does not adversely affect short-term glycemic control in persons with diabetes mellitus (an umbrella term for all forms of diabetes). However, there are many forms of diabetes mellitus and the test results submitted to the FDA were vague, inconsistent, and did not separate the different forms of diabetes in the safety studies.

For example, a single-dose crossover study (FDA study E156) was performed on 13 insulin-dependent (Type I diabetics) and 13 non-insulin dependent diabetics (Type II diabetics) to evaluate the effects of a single dose (at various milligrams) of sucralose on short-term glucose homeostasis in people with diabetes mellitus (the study did not specifically define test parameters as to which type of diabetes mellitus was being tested). The following inconsistencies occurred:

1. Fasting plasma glucose area under the curve (AUC) and fasting serum C-peptide AUC were measured after consumption of a standardized liquid breakfast meal with no mention of fasting after midnight the night prior to the test.2. Studies showed that neither plasma glucose nor serum C-peptide levels were affected by the single dose administration of sucralose - again with no mention of fasting the night before. If research subjects had fasted, serum and glucose levels would not be affected in the same way.3. From this submitted study, the FDA concluded that sucralose did not adversely affect short-tern glycemic control in persons with diabetes mellitus. These studies were not consistent, nonetheless -serum insulin levels measured in the studies showed a small but statistically significant increase in the glycoslyation (long-term blood glucose levels) of hemoglobin (HbA1c).4. Because of the small patient group sizes in the studies, the ultimate clinical significance of the observed HbA1c effect could not be determined. (No reasons were given.)

Note: increases in glycoslyation imply lessening control of diabetes.

The repeated McNeil tests submitted to the FDA on diabetic safety were performed using lower doses of sucralose from the doses used in previous tests, yet the differences in dosage are not emphasized. Also, there is no mention of fasting after midnight the previous night in any of the tests submitted.

The diabetic studies on which McNeil bases their claims of diabetic safety show that neither plasma glucose nor serum C-peptide levels were affected by a single dose of administered sucralose - again with no mention of fasting the night before. If fasting had taken place, serum and glucose levels would not be affected in the same way.

Bottom line, the safety of Splenda for diabetics is inconclusive according to the research documents submitted by McNeil to the FDA. And we must never forget to listen to the people with diabetes who use Splenda. Many have noted blood sugar spikes after using products with Splenda.

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